Discoscopes, Cervical Endoscopes

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Model / Reference

225-127-030

FDA applicant

Rz Medizintechnik GmbH

Primary DI / UDI-DI

04049197137072

Basic UDI-DI

40491975END-XXX-OPEQK

Direct Marketing DI

04049197137072

510(k) Number

K130778 ↗

FDA Product Code

HRX

EMDN Code

Z12021101 Arthroscopes

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 888.1100

EU market of registration

Germany

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Endoscopes

  Class IIa

  CE/MDR

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  CE/MDR

• Endoscopes

  Class IIa

  CE/MDR

• Endoscopes

  Class IIa

  CE/MDR

• Endoscopes

  Class IIa

  CE/MDR

• Endoscopes

  Class IIa

  CE/MDR

See all devices from RZ-Medizintechnik GmbH →

• What types of procedures are these cervical endoscopes primarily used for in spinal surgery?

  These Discoscopes, Cervical Endoscopes are designed specifically for arthroscopic visualization of the cervical spine. They provide direct optical access to intervertebral discs, joint spaces, and surrounding soft tissues, making them suitable for both diagnostic evaluations and therapeutic interventions in cervical spine procedures.

• Are these endoscopes reusable or intended for single-use, and how should they be stored?

  The Discoscopes, Cervical Endoscopes are explicitly intended for single-use applications. They are supplied sterile, so no reprocessing is required. Storage should follow standard sterile instrument protocols to maintain integrity until use.

• What regulatory pathways have these endoscopes undergone, and what does that mean for their use?

  These endoscopes have undergone FDA 510(k) clearance (traditional review, classified under product code HRX) and comply with MDR (Medical Device Regulation) requirements. This means they meet U.S. and EU regulatory standards for safety and performance in orthopedic settings, specifically for cervical spine arthroscopy.

• Are there different sizes or configurations available for these cervical endoscopes?

  Yes, the Discoscopes, Cervical Endoscopes come in standardized sizes and configurations tailored for cervical spine procedures. While exact dimensions aren’t specified, their design ensures compatibility with arthroscopic techniques in the cervical region.

• Can these endoscopes be used in MRI environments, or are there any compatibility concerns?

  The product documentation does not specify MRI compatibility for these endoscopes. If MRI use is required, additional verification or alternative devices may be necessary to avoid interference or safety risks.